The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery
Primary Purpose
Achilles Tendon Rupture
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immobilization duration
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring immobilization duration, open surgery, early rehabilitation
Eligibility Criteria
Inclusion Criteria:
- acute closed single-legged complete Achilles tendon rupture
- age of 18 to 60 years.
Exclusion Criteria:
- patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).
- an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm)
- those without rehabilitation or follow-up outcomes.
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
0-week immobilization
2-week immobilization
4-week immobilization
6-week immobilization
Arm Description
0-week brace immobilization after the surgery will be conducted.
2-week brace immobilization after the surgery will be conducted.
4-week brace immobilization after the surgery will be conducted.
6-week brace immobilization after the surgery will be conducted.
Outcomes
Primary Outcome Measures
the time of return to light sports activity
when the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.
Secondary Outcome Measures
range of motion (ROM) recovery time
the recovery time will be recorded when the ROM is similar to that of the uninjured side.
recovery time of the single-legged heel rise height (SHRH)
The heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.
Full Information
NCT ID
NCT04663542
First Posted
September 16, 2020
Last Updated
December 6, 2020
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04663542
Brief Title
The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery
Official Title
A Prospective Randomized Controlled Clinical Trial on the Comparison of the Treatment Outcomes of Different Immobilization Times After the Repair of Achilles Tendon Rupture
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups.
Detailed Description
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilization times by dividing the patients into four groups-A, B, C, and D-based on the amount of immobilization time (0, 2, 4, and 6 weeks, respectively) that include a similar rehabilitation protocol. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique and undergo a similar rehabilitation protocol after the brace is removed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
immobilization duration, open surgery, early rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0-week immobilization
Arm Type
Experimental
Arm Description
0-week brace immobilization after the surgery will be conducted.
Arm Title
2-week immobilization
Arm Type
Experimental
Arm Description
2-week brace immobilization after the surgery will be conducted.
Arm Title
4-week immobilization
Arm Type
Other
Arm Description
4-week brace immobilization after the surgery will be conducted.
Arm Title
6-week immobilization
Arm Type
Other
Arm Description
6-week brace immobilization after the surgery will be conducted.
Intervention Type
Procedure
Intervention Name(s)
immobilization duration
Intervention Description
brace immobilization duration after open surgery for Achilles tendon rupture
Primary Outcome Measure Information:
Title
the time of return to light sports activity
Description
when the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.
Time Frame
from operation to 1-year follow-up after the surgery
Secondary Outcome Measure Information:
Title
range of motion (ROM) recovery time
Description
the recovery time will be recorded when the ROM is similar to that of the uninjured side.
Time Frame
from operation to 1-year follow-up after the surgery
Title
recovery time of the single-legged heel rise height (SHRH)
Description
The heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.
Time Frame
from operation to 1-year follow-up after the surgery
Other Pre-specified Outcome Measures:
Title
visual analogue scale (VAS)
Description
VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.
Time Frame
2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Title
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
Description
The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
Time Frame
2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Title
the Achilles tendon Total Rupture Score (ATRS)
Description
The ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations.
Time Frame
2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute closed single-legged complete Achilles tendon rupture
age of 18 to 60 years.
Exclusion Criteria:
patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).
an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm)
those without rehabilitation or follow-up outcomes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Lv, M.D.
Phone
+86-18513112060
Email
lvyang42@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangyu Xu, M.D.
Phone
+86-15210849431
Email
307542744@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Lv, M.D.
Phone
+8610-82267010
Email
zhouf@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiangyu Xu, M.D.
Phone
+86-15210849431
Email
307542744@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery
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